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Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension

Developing a Hemodynamics Based Noninvasive Diagnostic Platform for Liver Fibrosis/Cirrhosis and Portal Hypertension

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03277651
Enrollment
200
Registered
2017-09-11
Start date
2017-10-09
Completion date
2020-12-31
Last updated
2018-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver Fibrosis, Portal Hypertension

Keywords

noninvasive, Hemodynamics

Brief summary

This study is to establish a noninvasive diagnostic platform based on hemodynamic information for the assessment of liver fibrosis, liver cirrhosis and portal hypertension.

Detailed description

As the hemodynamics of liver vessels depend on the liver tissue mechanics, we hypothesize that the hemodynamics measurements of the liver are strongly correlated with the stages of liver fibrosis and portal hypertension, and can therefore serve as an alternative means of diagnosis. We have developed a physics-based mathematical model that incorporates our biological understanding of fibrosis development. The model quantitatively predicts changes of liver tissue stiffness and blood flow dynamics as a function of fibrosis stage. Preliminary data using ultrasound Doppler images and needle biopsy from liver fibrosis patients have suggested the 'prove of principle. We propose further test our hypothesis by collecting and analyzing ultrasound Doppler and biopsy data to confirm the correlation between blood flow dynamics and disease stage from patients with hepatic fibrosis and portal hypertension. If tested true, we can expect to use features of ultrasound Doppler as a non-invasive means of diagnosis for fibrosis and portal hypertension.

Interventions

DIAGNOSTIC_TESThemodynamics tests

Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Inpatients who undergo liver biopsy or hepatic venous pressure gradient test

Exclusion criteria

* decompensated liver diseases (including ascites, variceal bleeding or hepatic encephalopathy); * alpha-fetoprotein \>100 ng/ml or serum creatinine \>1.5 × upper limit of normal (ULN); * any malignant tumor; * any complications of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases; * severe neurological or psychological disease; * pregnant or lactating women.

Design outcomes

Primary

MeasureTime frameDescription
SensitivitybaselineDiagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
SpecificitybaselineDiagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
Positive predictive value (PPV)baselineDiagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
Negative predictive value (NPV)baselineDiagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
Area under ROC curve (AUROC)baselineDiagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension

Countries

China

Contacts

Primary ContactShengdi Wu
wu.shengdi@zs-hospital.sh.cn0086-021-64041990
Backup ContactWei Jiang
jiang.wei@zs-hospital.sh.cn0086-021-64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026